What side effects are associated with this type of intervention?

Common treatments for ovarian tumors, particularly those involving topoisomerase 1 inhibitors like topotecan, often result in side effects such as myelosuppression (including neutropenia, anemia, and thrombocytopenia), gastrointestinal disturbances (nausea, vomiting, diarrhea), and fatigue. Targeted therapies, such as those involving folate receptor alpha, may also cause specific toxicities related to the targeted delivery mechanism, but detailed side effect profiles for novel agents like ELU001 are still under investigation.

What prior FDA approvals exist?

FDA-approved treatments for ovarian tumors have included various chemotherapeutic agents and targeted therapies. Notably, topoisomerase 1 inhibitors like topotecan have been used, although not specifically in a targeted delivery format like ELU001. Other targeted therapies include bevacizumab, which targets vascular endothelial growth factor (VEGF), and PARP inhibitors such as olaparib for BRCA-mutated ovarian cancer. While ELU001 represents a novel approach by targeting folate receptor alpha for the delivery of topoisomerase 1 inhibitors, similar targeted delivery mechanisms have not yet been widely approved.

What other types of research exist?

Promising novel alternatives to ELU001 for ovarian tumor patients include PARP inhibitors like olaparib and rucaparib, which have shown efficacy in patients with BRCA mutations and platinum-sensitive relapsed ovarian cancer. Additionally, pegylated liposomal doxorubicin (PLD) is a viable option for platinum-resistant disease due to its favorable side effect profile and similar efficacy to other agents like topotecan and paclitaxel.

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Topoisomerase I inhibitors

ELU001 for Ovarian and Endometrial Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Elucida Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1

Must not have

Taken any treatments that use the protein folate receptor alpha or FRα to work

Active or ongoing eye disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose of study drug until responses of cr or pr, assessed up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ELU001, a new drug that targets advanced cancers by delivering cancer-fighting chemicals directly to the cancer cells. It focuses on adults with difficult-to-treat cancers that overproduce a specific protein and have no other treatment options. The drug acts like a guided missile, aiming to kill cancer cells while sparing healthy ones.

Who is the study for?

Adults with advanced, recurrent or refractory tumors that have high levels of a protein called folate receptor alpha (FRα) and are sensitive to certain chemotherapy drugs. Participants must be in fairly good health, not pregnant or planning to become so, have recovered from any surgeries, and lack other treatment options.

What is being tested?

ELU001 is being tested; it's a new type of drug-conjugate designed to target cancer cells overexpressing FRα. It combines a chemotherapy agent with folic acid analogs linked to a carrier particle, aiming for precise delivery to the tumor while sparing healthy tissue.

What are the potential side effects?

Specific side effects of ELU001 aren't detailed here but may include typical reactions related to chemotherapy such as fatigue, nausea, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer can be measured by standard tests or, if not, it still follows certain criteria.

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I have no other treatment options that could significantly extend my life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken treatments targeting the protein folate receptor alpha.

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I have an active eye condition.

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I haven't had serious heart problems or other cancers in the last 3 years.

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My cancer has spread to my brain.

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I do not have an active autoimmune disease needing immune-suppressing drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose of study drug until responses of cr or pr, assessed up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose of study drug until responses of cr or pr, assessed up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose of study drug until responses of cr or pr, assessed up to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 Dose Escalation: The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.

Part 2 Dose Expansion: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.

Secondary study objectives

Part 1 Dose Escalation: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.

Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.

Part 1 and Part 2: To determine Duration of Response (DOR) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ELU001Experimental Treatment1 Intervention

Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian tumors often involve targeted therapies and chemotherapeutic agents. ELU001, for example, is a novel treatment that uses a C'Dot drug conjugate to deliver topoisomerase 1 inhibitors directly to cancer cells overexpressing folate receptor alpha. This targeted approach allows for higher concentrations of the drug at the tumor site, potentially increasing efficacy while reducing systemic side effects. Other treatments include platinum-based chemotherapies (e.g., carboplatin and cisplatin), which cause DNA crosslinking and damage, and PARP inhibitors (e.g., olaparib), which block DNA repair in cancer cells with BRCA mutations. These mechanisms are crucial for ovarian tumor patients as they offer more effective and personalized treatment options, potentially improving outcomes and quality of life.

Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation BRCA1-Del ex9-12.Promising novel therapies for the treatment of endometrial cancer.